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Veteran-Centered Care for Advanced Liver Disease (I-VCALD Trial)

N/A

Waitlist Available

Led By Fasiha Kanwal, MD MSHS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have AdvLD, defined based on two ambulatory or one inpatient encounter ICD-10 codes for new onset cirrhosis complications or MELD-Na >15 in the previous 12 months

Patients will be between 18 and 80 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months

Awards & highlights

I-VCALD Trial Summary

This trial aims to help Veterans suffering from advanced liver disease by using a whole person, Veteran-centered approach to identify and match them with curative and supportive care. Outcomes of the study will inform how to better help those suffering.

Who is the study for?

This trial is for Veterans aged 18-80 with advanced liver disease who have been in care at a recruiting site for over a year. They must speak English, have phone or computer access, and be able to consent. Those already on the transplant list or with limited life expectancy are excluded.Check my eligibility

What is being tested?

The I-VCALD study tests a telemedicine-based approach where nurses help Veterans understand their illness, identify care preferences, and align treatment options. It aims to increase rates of liver transplant consideration and serious illness discussions.See study design

What are the potential side effects?

Since this intervention involves counseling rather than medication, typical drug side effects aren't expected. However, participants may experience emotional distress when discussing serious health issues.

I-VCALD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have advanced liver disease with recent complications or a MELD-Na score over 15.

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I am between 18 and 80 years old.

I-VCALD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

EHR documentation of consideration for liver transplantation change

EHR documentation of goals of care conversation change

Secondary outcome measures

Health Related Quality of Life (HRQoL)

Perceived quality of shared decision-making

Quality of symptomatic advanced liver disease (AdvLD) care

+2 more

I-VCALD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1: I-VCALD InterventionExperimental Treatment1 Intervention

I-VCALD Participants will receive the standard of care from their usual VA healthcare provider, plus they will participate in 5 monthly 60-minute care counselor sessions over a period of 6 months via VA Video Connect (VVC) or by telephone. The purpose of care counselor visits is to assess and cultivate the patient's understanding of their illness and identify personal healthcare goals. The counselor will be part of a centralized research care team (hepatologist and supportive care physician) and will work with each patient's usual VA care providers to help tailor treatment plans and education to better align with each patient's understanding of their disease prognosis and their healthcare goals and priorities.

Group II: Arm 2: Usual CareActive Control1 Intervention

Usual Care Participants will receive the standard of care from their usual VA healthcare provider. The care counselor will not contact the usual care condition participants.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,612 Previous Clinical Trials

3,305,293 Total Patients Enrolled

Fasiha Kanwal, MD MSHSPrincipal InvestigatorMichael E. DeBakey VA Medical Center, Houston, TX

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research trial encompass individuals aged 80 and above?

"The age restrictions for this trial are individuals aged 18 or above, and below 80."

Answered by AI

Are volunteers needed for this research project?

"As per the clinicaltrials.gov website, this medical trial is not currently recruiting patients as it was last updated on September 28th 2023; nonetheless there are 269 other trials actively enrolling participants at present."

Answered by AI

Are there any health facilities within the state that are conducting this experiment?

"Currently, the 4 medical sites taking part in this study are located in Palo Alto, West Los Angeles and Houston as well as a few other places. If you decide to join the trial, it is beneficial to choose a location close by so that traveling costs can be minimized."

Answered by AI

Is it possible for me to be enrolled in this trial?

"Patients aged between 18 and 80 suffering from liver disease can qualify for this trial, which is presently recruiting 450 individuals."

Answered by AI

What are the underlying goals of this clinical research?

"Over the course of 6 and 12 months, this clinical trial will assess whether EHR documentation relating to goals of care conversations changes. Secondary evaluation criteria includes Health Related Quality of Life (HRQoL), which is quantified using PROMIS-10; Perceived quality of shared decision-making measured with CollaboRATE scale; as well as Satisfaction with Care assessed by a Feeling Heard and Understood survey. All scores are represented on an 0 to 16 point range, wherein higher marks indicate improved HRQoL, enhanced shared decisions making processes, and increased satisfaction with care."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Integrating Veteran-Centered Care for Advanced Liver Disease (I-VCALD)

2024. "Integrating Veteran-Centered Care for Advanced Liver Disease (I-VCALD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06068491.

All > Liver Disease